EASY CARE FIRST AID DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, film coated 
Tender Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Easy Care First Aid Ibuprofen

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

Temporarily relieves these symptoms due to the common cold

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on skin.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcohol beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of overdose, contact a physician or poison control center immediately.

Directions

Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

* may contain

Easy Care First Aid Diphenhydramine

1 Caplet

Made in USA

See card for complete product information

Diphenhydramine

EASY CARE FIRST AID DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-0017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorpink (pink) Scoreno score
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code 048;D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44224-0017-250 in 1 BOX01/01/2012
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC:44224-0017-11 in 1 PACKET; Type 0: Not a Combination Product01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2012
Labeler - Tender Corporation (064437304)

Revised: 10/2019
Document Id: 9405f355-4b72-1caf-e053-2a95a90af018
Set id: 9405f355-4b71-1caf-e053-2a95a90af018
Version: 1
Effective Time: 20191003
 
Tender Corporation